Comparison of lotions, creams, gels and ointments for the treatment of childhood eczema: the BEE RCT.

Background: Emollients are recommended for children with eczema (atopic eczema/dermatitis). A lack of head-to-head comparisons of the effectiveness and acceptability of the different types of emollients has resulted in a 'trial and error' approach to prescribing. Objective: To compare the effectiveness and acceptability of four commonly used types of emollients for the treatment of childhood eczema. Design: Four group, parallel, individually randomised, superiority randomised clinical trials with a nested qualitative study, completed in 2021. A purposeful sample of parents/children was interviewed at ≈ 4 and ≈ 16 weeks. Setting: Primary care (78 general practitioner surgeries) in England. Participants: Children aged between 6 months and 12 years with eczema, of at least mild severity, and with no known sensitivity to the study emollients or their constituents. Interventions: Study emollients sharing the same characteristics in the four types of lotion, cream, gel or ointment, alongside usual care, and allocated using a web-based randomisation system. Participants were unmasked and the researcher assessing the Eczema Area Severity Index scores was masked. Main outcome measures: The primary outcome was Patient-Oriented Eczema Measure scores over 16 weeks. The secondary outcomes were Patient-Oriented Eczema Measure scores over 52 weeks, Eczema Area Severity Index score at 16 weeks, quality of life (Atopic Dermatitis Quality of Life, Child Health Utility-9 Dimensions and EuroQol-5 Dimensions, five-level version, scores), Dermatitis Family Impact and satisfaction levels at 16 weeks. Results: A total of 550 children were randomised to receive lotion (analysed for primary outcome 131/allocated 137), cream (137/140), gel (130/135) or ointment (126/138). At baseline, 86.0% of participants were white and 46.4% were female. The median (interquartile range) age was 4 (2-8) years and the median Patient-Oriented Eczema Measure score was 9.3 (SD 5.5). There was no evidence of a difference in mean Patient-Oriented Eczema Measure scores over the first 16 weeks between emollient types (global p = 0.765): adjusted Patient-Oriented Eczema Measure pairwise differences - cream-lotion 0.42 (95% confidence interval -0.48 to 1.32), gel-lotion 0.17 (95% confidence interval -0.75 to 1.09), ointment-lotion -0.01 (95% confidence interval -0.93 to 0.91), gel-cream -0.25 (95% confidence interval -1.15 to 0.65), ointment-cream -0.43 (95% confidence interval -1.34 to 0.48) and ointment-gel -0.18 (95% confidence interval -1.11 to 0.75). There was no effect modification by parent expectation, age, disease severity or the application of UK diagnostic criteria, and no differences between groups in any of the secondary outcomes. Median weekly use of allocated emollient, non-allocated emollient and topical corticosteroids was similar across groups. Overall satisfaction was highest for lotions and gels. There was no difference in the number of adverse reactions and there were no significant adverse events. In the nested qualitative study (n = 44 parents, n = 25 children), opinions about the acceptability of creams and ointments varied most, yet problems with all types were reported. Effectiveness may be favoured over acceptability. Parents preferred pumps and bottles over tubs and reported improved knowledge about, and use of, emollients as a result of taking part in the trial. Limitations: Parents and clinicians were unmasked to allocation. The findings may not apply to non-study emollients of the same type or to children from more ethnically diverse backgrounds. Conclusions: The four emollient types were equally effective. Satisfaction with the same emollient types varies, with different parents/children favouring different ones. Users need to be able to choose from a range of emollient types to find one that suits them. Future work: Future work could focus on how best to support shared decision-making of different emollient types and evaluations of other paraffin-based, non-paraffin and 'novel' emollients. Trial registration: This trial is registered as ISRCTN84540529 and EudraCT 2017-000688-34. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (HTA 15/130/07) and will be published in full in Health Technology Assessment; Vol. 27, No. 19. See the NIHR Journals Library website for further project information.

One in five children in the UK have eczema, a long-term, itchy, dry skin condition. It can significantly affect both the child and their family. Most children are diagnosed and looked after by their family doctor (general practitioner) and are prescribed moisturisers (also called emollients) to relieve skin dryness and other creams (topical corticosteroids) to control flare-ups. However, there are many different types of emollients and, to our knowledge, limited research to show which is better. In the Best Emollients for Eczema clinical trial, we compared the four main types of moisturisers ­ lotions, creams, gels and ointments. These types vary in their consistency, from thin to thick. We recruited 550 children (most of whom were white and had moderate eczema) and randomly assigned them to use one of the four different types as their main moisturiser for 16 weeks. We found no difference in effectiveness. Parent-reported eczema symptoms, eczema severity and quality of life were the same for all the four types of moisturisers. However, overall satisfaction was highest for lotions and gels. Ointments may need to be used less and cause less stinging. We interviewed 44 parents and 25 children who took part. Opinions of all four types of moisturisers varied. What one family liked about a moisturiser was not necessarily the same for another and preferences were individual to each user. Sometimes there was a tension between how well a moisturiser worked (effectiveness) and how easy it was to use (acceptability). In these cases, effectiveness tended to decide whether or not parents kept using it. People found moisturisers in pumps and bottles easier to use than those in tubs. A number of participants valued the information they were given about how to use moisturisers. Our results suggest that the type of moisturiser matters less than finding one that suits the child and family.

Effectiveness and safety of lotion, cream, gel, and ointment emollients for childhood eczema: a pragmatic, randomised, phase 4, superiority trial.

BACKGROUND: To our knowledge, there are no trials comparing emollients commonly used for childhood eczema. We aimed to compare the clinical effectiveness and safety of the four main emollient types: lotions, creams, gels, and ointments. METHODS: We did a pragmatic, individually randomised, parallel group, phase 4 superiority trial in 77 general practice surgeries in England. Children aged between 6 months and 12 years with eczema (Patient Orientated Eczema Measure [POEM] score >2) were randomly assigned (1:1:1:1; stratified by centre and minimised by baseline POEM score and age, using a web-based system) to lotions, creams, gels, or ointments. Clinicians and parents were unmasked. The initial emollient prescription was for 500 g or 500 mL, to be applied twice daily and as required. Subsequent prescriptions were determined by the family. The primary outcome was parent-reported eczema severity over 16 weeks (weekly POEM), with analysis as randomly assigned regardless of adherence, adjusting for baseline and stratification variables. Safety was assessed in all randomly assigned participants. This trial was registered with the ISRCTN registry, ISRCTN84540529. FINDINGS: Between Jan 19, 2018, and Oct 31, 2019, 12 417 children were assessed for eligibility, 550 of whom were randomly assigned to a treatment group (137 to lotion, 140 to cream, 135 to gel, and 138 to ointment). The numbers of participants who contributed at least two POEM scores and were included in the primary analysis were 131 in the lotion group, 137 in the cream group, 130 in the gel group, and 126 in the ointment group. Baseline median age was 4 years (IQR 2-8); 255 (46%) participants were girls, 295 (54%) were boys; 473 (86%) participants were White; and the mean POEM score was 9·3 (SD 5·5). There was no difference in eczema severity between emollient types over 16 weeks (global p value=0·77), with adjusted POEM pairwise differences of: cream versus lotion 0·42 (95% CI -0·48 to 1·32), gel versus lotion 0·17 (-0·75 to 1·09), ointment versus lotion -0·01 (-0·93 to 0·91), gel versus cream -0·25 (-1·15 to 0·65), ointment versus cream -0·43 (-1·34 to 0·48), and ointment versus gel -0·18 (-1·11 to 0·75). This result remained unchanged following multiple imputation, sensitivity, and subgroup analyses. The total number of adverse events did not significantly differ between the treatment groups (lotions 49 [36%], creams 54 [39%], gels 54 [40%], and ointments 48 [35%]; p=0·79), although stinging was less common with ointments (12 [9%] of 138 participants) than lotions (28 [20%] of 137), creams (24 [17%] of 140), or gels (25 [19%] of 135). INTERPRETATION: We found no difference in effectiveness between the four main types of emollients for childhood eczema. Users need to be able to choose from a range of emollients to find one that they are more likely to use effectively. FUNDING: National Institute for Health and Care Research.

Engaging with diverse audiences to raise awareness about childhood eczema: reflections from two community events.

BACKGROUND: Eczema is a common childhood condition, causing dry and itchy skin which can be difficult to manage. We have been undertaking eczema and food allergy research to address previously prioritised research questions. We obtained funding to trial novel approaches to reach diverse audiences to raise awareness of childhood eczema, research, and public involvement in research. METHODS: This paper reflects on two public engagement events held in collaboration with stakeholders in two settings of ethnic diversity in East Bristol, UK. We invited parents and children to attend the events by public display of posters. We created novel activities related to the research and involved artists to engage parents/carers and children about eczema and the research we are doing into its management. RESULTS: Attendance at the first event was lower than expected. Lessons learned were incorporated into the second event, to use a more structured approach and attract greater numbers of parents/carers from more diverse backgrounds. Creative approaches such as using artists at both events made the subject more accessible for diverse audiences, including children. CONCLUSION: We successfully delivered two public engagement events. The success of the events has generated individual interest in PPI and enquiries about future events from neighbouring community groups. Reflections from the events have also been fed back to inform the research.

People and teams matter in organizational change: professionals' and managers' experiences of changing governance and incentives in primary care.

OBJECTIVES: To explore the experiences of governance and incentives during organizational change for managers and clinical staff. STUDY SETTING: Three primary care settings in England in 2006-2008. STUDY DESIGN: Data collection involved three group interviews with 32 service users, individual interviews with 32 managers, and 56 frontline professionals in three sites. The Realistic Evaluation framework was used in analysis to examine the effects of new policies and their implementation. PRINCIPAL FINDINGS: Integrating new interprofessional teams to work effectively is a slow process, especially if structures in place do not acknowledge the painful feelings involved in change and do not support staff during periods of uncertainty. CONCLUSIONS: Eliciting multiple perspectives, often dependent on individual occupational positioning or place in new team configurations, illuminates the need to incorporate the emotional as well as technocratic and system factors when implementing change. Some suggestions are made for facilitating change in health care systems. These are discussed in the context of similar health care reform initiatives in the United States.

Financial and clinical risk in health care reform: a view from below.

OBJECTIVES: This paper examines how the interaction between financial and clinical risk at two critical phases of health care reform in England has been experienced by frontline staff caring for vulnerable patients with long term conditions. METHODS: The paper draws on contracting theory and two interdisciplinary and in-depth qualitative research studies undertaken in 1995 and 2007. Methods common to both studies included documentary analysis and interviews with managers and front line professionals. The 1995 study employed action-based research and included observation of community care; the 2007 study used realistic evaluation and included engagement with service user groups. RESULTS: In both reform processes, financial risk was increasingly devolved to frontline practitioners and smaller organizational units such as GP commissioning groups, with payment by unit of activity, aimed at changing professionals' behaviour. This financing increased perceived clinical risk and fragmented the delivery of health and social care services requiring staff efforts to improve collaboration and integration, and created some perverse incentives and staff demoralisation. CONCLUSIONS: Health services reform should only shift financial risk to frontline professionals to the extent that it can be efficiently borne. Where team work is required, contracts should reward collaborative multi-professional activity.

Prevalence of abnormal bone density of pediatric patients prior to blood or marrow transplant.

Osteoporosis and osteopenia are long-term side effects of bone marrow transplant (BMT). The purpose of this study was to determine the prevalence of bone mineral density (BMD) abnormalities in pediatric patients prior to BMT. Forty-four pediatric patients were evaluated with DEXA scans. The average Z-score was -0.37. Thirty-six percent had abnormal BMD. Sixty-seven percent of ALL patients had abnormal BMD. Patients with non-malignant diseases were significantly more likely to have abnormal BMD. Patients with ALL had more defects than solid tumor patients. Females had more defects than males. These results demonstrate BMD defects are common in children prior to BMT, especially in patients with ALL.

Women's interpretation of cardiac symptoms at the time of their cardiac event: the effect of co-occurring illness.

BACKGROUND: Women tend to access medical help for a myocardial infarction later than men and are at a disproportionate risk of dying or of suffering disability as a consequence. Co-morbidity is associated with delay but little is known how this affects decision making. AIM: To examine the effect of co-occurring chronic illness or infections on women's interpretation of their symptoms and action at the time of their cardiac event. METHODS: Semi-structured interviews with 44 women admitted to 3 district hospitals following a cardiac event. For the purposes of analysis they were divided into those who arrived at the hospital within 12 h of onset of symptoms (<12 hour group) and those who took more than 12 h (>12 hour group). FINDINGS: Women utilised their mental records of knowledge and experiences to make sense of their cardiac symptoms. The mental records of the <12 hour group contained knowledge of symptoms and previous experiences relevant to cardiac problems. Those of the >12 hour group contained knowledge and experience of recent and co-occurring chronic illnesses, this provided persuasive 'evidence' to suggest that their symptoms were normal or typical for their current state of health and resulted in delay. CONCLUSION: Women's decision making and timely access to medical help at the time of a cardiac event is influenced by their repertoire of knowledge and experience. Interventions need to be designed to capture the process of symptom recognition and the influence of co-morbidity.

Lymphocytes: not useless after all.

Half a century ago, an immunologist named N. Avrion Mitchison showed that lymphocytes--then thought to be useless--triggered tumor rejection in mice.